Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

Q: Who is the manufacturer of Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

Brainlab AG filed the 510(k) submission for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (K192703).

Q: What is the FDA product code for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

Cranial Image Guided Surgery System (K092467); VectorVision Fluoro 3D (K070106).

Q: Who can help prepare an FDA 510(k) submission like Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K192703 · Brainlab AG · HAW · Oct 8, 2020 · Neurology

Device Facts

Record ID	K192703
Device Name	Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
Applicant	Brainlab AG
Product Code	HAW · Neurology
Decision Date	Oct 8, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including: · Cranial Resection · Resection of tumors and other lesions · Resection of skull-base tumor or other lesions · AVM Resection · Cranial biopsies · Intracranial catheter placement · Intranasal structures and Paranasal Sinus Surgery · Functional endoscopic sinus surgery (FESS) · Revision & distorted anatomy surgery all intranasal structures and paranasal sinuses

Device Story

Cranial IGS System enables navigated surgery by linking physical instruments to virtual patient image data. System uses infrared camera to track passive marker arrays fixed to patient head; aligns patient anatomy to digital images (CT, CTA, X-Ray, MR, MRA, ultrasound) via surface/landmark registration or coordinate transformations. Used in hospital operating rooms by neurosurgeons and ENT surgeons. Provides real-time visualization of instrument position relative to anatomy on navigation platform display. Facilitates precise surgical planning and navigation for cranial resections, biopsies, catheter placements, and sinus procedures. Benefits include improved surgical accuracy and minimally invasive guidance.

Clinical Evidence

Bench testing only. Performance verification included system-level software verification, integration testing, and component-level code verification. Non-clinical accuracy testing demonstrated a mean location error of 1.3 mm (SD 0.5 mm, 99th percentile 2.2 mm) and a mean trajectory angle error of 0.73° (SD 0.34°, 99th percentile 1.3°). Usability testing confirmed safe operation.

Technological Characteristics

Infrared tracking system using passive marker arrays. Compatible with Brainlab Kick, Curve, and Buzz IGS platforms. Supports Windows 7, 8.1, and 10. Software-based navigation system; instruments include sterile components for bone/soft tissue contact. Connectivity via IGS platform. Sterilization required for surgical instruments.

Indications for Use

Indicated for patients requiring image-guided surgery where rigid anatomical structures can be referenced to CT, CTA, X-Ray, MR, MRA, or ultrasound images. Procedures include cranial resection (tumors, skull-base lesions, AVM), cranial biopsies, intracranial catheter placement, and intranasal/paranasal sinus surgery (FESS, revision/distorted anatomy). No specific age or gender contraindications.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

Cranial Image Guided Surgery System (K092467)
VectorVision Fluoro 3D (K070106)

Related Devices

K023651 — VECTORVISION CRANIAL/ENT · Brainlab AG · Feb 17, 2004
K092467 — VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED · Brainlab AG · May 6, 2010
K022239 — SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM · Praxim · Aug 23, 2002
K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software · Medtronic Navigation, Inc. · Mar 31, 2017
K062640 — STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 · Stryker Instruments · Dec 14, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". October 8, 2020 Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 DE Re: K192703 Trade/Device Name: Cranial Image Guided Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 2, 2020 Received: September 8, 2020 Dear Chiara Cunico: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192703 #### Device Name Cranial Image Guided Surgery System The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including: - · Cranial Resection - · Resection of tumors and other lesions - · Resection of skull-base tumor or other lesions - · AVM Resection - · Cranial biopsies - Intracranial catheter placement - · Intranasal structures and Paranasal Sinus Surgery - · Functional endoscopic sinus surgery (FESS) - · Revision & distorted anatomy surgery all intranasal structures and paranasal sinuses Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY CRANIAL IMAGE GUIDED SURGERY SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92 | GENERAL INFORMATION | | | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer: | Brainlab AG Olof-Palme-Straße 9 81829 Munich Germany Ph: + 49-899915681 0 Fax: +49 89 991568 5033 | | | Establishment Registration #: | 8043933 | | | Date of preparation: | October 8th, 2020 | | | Device Name: | Cranial Image Guided Surgery System | | | Trade Name(s): | Navigation Software Cranial Navigation Software ENT Registration Software Cranial Automatic Registration 2.0 Ultrasound Navigation Software (BK) Intraoperative Structure Update | | | Classification Name: | Neurological Stereotaxic Instrument, 21 CFR 882.4560 | | | Classification Product Code | HAW | | | Review Panel: | Neurology | | | Device Class: | Class II | | | Primary Predicate Device: | K092467, Cranial Image Guided Surgery System, by Brainlab AG | | | Secondary Predicate Device: | K070106, VectorVision Fluoro 3D, by Brainlab AG | | {4}------------------------------------------------ | CONTACT INFORMATION | | |-----------------------------------|----------------------------------------| | Primary contact person | Alternative contact person | | Chiara Cunico | Regulatory Affairs Brainlab | | Manager RA | Email: regulatory.affairs@brainlab.com | | phone: +49 89 99 15 68 1738 | phone: +49 89 99 15 68 0 | | Email: Chiara.cunico@brainlab.com | fax: +49 89 99 15 68 5033 | # INTENDED USE / INDICATIONS FOR USE Cranial IGS System: The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image-guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT. CTA. X-Ray. MR. MRA and ultrasound) of the anatomy. including: #### · Cranial Resection - · Resection of tumors and other lesions - · Resection of skull-base tumor or other lesions - · AVM Resection - · Cranial biopsies - · Intracranial catheter placement - · Intranasal structures and Paranasal Sinus Surgery - · Functional endoscopic sinus surgery (FESS) - · Revision & distorted anatomy surgery all intranasal structures and paranasal sinuses # DEVICE DESCRIPTION The Cranial IGS System consists of software and hardware (instruments) components that when used with a compatible navigation or "IGS platform" enables navigated surgery. It links instruments in the real world or "patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial and ENT procedures. # OPERATOR PROFILE The application is intended to be used by medical professionals who perform neurosurgery and ENT surgery (e.g. neurosurgeons, surgeons' assistants and operating room personnel). # PATIENT POPULATION There are no demographic, regional or cultural limitations for patients. #### INTENDED USE ENVIRONMENT The system is developed to run on Brainlab IGS Platform, which shall be used in hospital environments, specifically in rooms which are appropriate for surgical interventions (e.g. operation rooms). {5}------------------------------------------------ # OPERATING PRINCIPLE The operating principle of the subject device is the following: - Infrared tracking: An infrared camera recognizes an infrared passive marker array which is in a fix position to the patient's head. Suitable instruments can be spatially tracked with respect to this marker array. Alignment of the patient's anatomy to the digital patient image data is performed through localizing surface skin points or landmarks points to the patient (this step is also known as registration). In addition for automatic registration methods, the alignment of the patient's anatomy to the digital patient image data is performed through coordinate transformations of localizing markers. This enables representing the position of a tracked instrument in relation to the patient's anatomy in digital patient image data (this step is also known as navigation). The Subject device interfaces with other Brainlab applications which provides, e.g. planning data. # INTENDED PART OF THE BODY OR TYPE OF TISSUE APPLIED TO OR INTERACTED WITH The intended part of body depends on the instrument used. Whereas the navigation software does not have any patient contact, some instruments are designed to be used in a sterile environment and also for getting in contact with the patient's bone or soft tissue. #### REASON FOR 510(K) SUBMISSION Additional indication and other changes that do not affect the fundamental scientific technology of the device. ### SUBSTANTIAL EQUIVALENCE The functionality of the subject device has been previously included in the Predicate Devices. The Subject Device specifically takes over the functionalities from the primary predicate device and moved them to separate applications to have dedicated applications for specific tasks. It takes over the ability to navigate on 2D fluoroscopic images, specially, Digital Subtraction Angiographies for arteriovenous malformation resection. {6}------------------------------------------------ | Technological Characteristics of the Subject Device in comparison to the primary predicate device | | Cleared device feature/specifications | Modified device feature/specifications | |---------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Intended Use / Indications for Use | Cranial Image Guided Surgery System (K092467) The Cranial IGS System is intended to be an intra- operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the navigation workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-Ray, MR, MRA and ultrasound based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies Pediatric Catheter Shunt Placement General Catheter Shunt Placement Thalamotomies/ Palliodotomies ENT Procedures Transphenoidal procedures Maximillary antrostomies Ethmoidectomies Spheno-idotomies/ sphenoid explorations Turbinate resections Frontal sinusotomies Intranasal procedures | Cranial Image Guided Surgery System The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image- guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X- Ray, MR, MRA and ultrasound) of the anatomy, including: Cranial Resection • Resection of tumors and other lesions • Resection of skull- base tumor or other lesions • AVM Resection Cranial biopsies Intracranial catheter placement Intranasal structures and Paranasal Sinus Surgery • Functional endoscopic sinus surgery (FESS) • Revision & distorted anatomy surgery on all intranasal structures and paranasal sinuses | | | Brainlab IGS Platform | Brainlab Kolibri Brainlab Vector Vision | Brainlab Kick Brainlab Curve | {7}------------------------------------------------ Technological Characteristics of the Sibject Device in comparison to the secondary predicate device | | | Brainlab Buzz IGS | |---------------------------------------|------------------------------|----------------------------------------| | Operating Systems | Windows XP | Windows 7 Windows 8.1 Windows 10 | | Data Inputs | Equivalent | | | Tracking Technology | Equivalent | | | Navigation Features | Equivalent | | | Angio Navigation Views | Navigation of CTA and MRA | Navigation of 2D DSA images | | Pre-calibrated Instrument Tracking | Equivalent | | | Calibrated Instrument Tracking | Equivalent | | | | Cleared device feature/specifications | Modified device feature/specifications | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | VectorVision Fluoro 3D (K070106) | Cranial Image Guided Surgery System | | Intended Use / Indications for Use | Brainlab Vector Vision fluoro3D is intended as an intraoperative image- guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data. VectorVision fluoro3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone | The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as an image- guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data that is being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X- Ray, MR, MRA and ultrasound) of the anatomy, including: | {8}------------------------------------------------ | | structures with precalibrated and additional individually- calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. | Cranial Resection • Resection of tumors and other lesions • Resection of skull- base tumor or other lesions • AVM Resection Cranial biopsies Intracranial catheter placement Intranasal structures and Paranasal Sinus Surgery • Functional endoscopic sinus surgery (FESS) • Revision & distorted anatomy surgery on all intranasal structures I and paranasal sinuses | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Brainlab IGS Platform | Brainlab Kolibri Brainlab Vector Vision | Brainlab Kick Brainlab Curve Brainlab Buzz IGS | | Operating Systems | Windows XP | Windows 7 Windows 8.1 Windows 10 | | Angio Navigation Views | Fluoro Navigation: Navigation of medical image data based on exact position display of instrument tip. | Angio Views: Navigation of medical image data based on exact position display of instrument tip. | Verification/Validation summary: #### Verification: Verification has been performed according to the Verification Plan and following internal processes to demonstrate that design specifications are met bv the device. The software changes have been tested in accordance with the Brainlab software development life cycle process. Verification and validation testing activities were performed at the software system, integration, and component levels to show sufficient implementation of the changes as per the specifications. Software testing conducted includes: - . System level software verification - Accuracy testing ● - Integration tests with other Brainlab software applications and . IGS platforms - . Component level code verification Furthermore, in accordance with the design controls process, the following tests were deemed required to evaluate the Cranial IGS System performance across the hardware and electrical components: - . Electrical safety - Electromagnetic compatibility (EMC) . {9}------------------------------------------------ - Biocompatibility . - Sterilization ● All testing was utilized to verify the subject device performance as intended. #### Validation: Validation of the functionalities, including nonclinical performance tests (accuracy tests, see below), has been performed in accordance with the internal processes. Usability tests have been performed as well to ensure that the device can be used safely and that measures against potential use related risks are effective. #### Nonclinical performance testing (Accuracy) The system has a mean accuracy of 2 mm for location error and 2° for trajectory angle error. The following table summarizes the performance verification results of the system: | | Mean | Standard deviation | 99th percentile | |---------------------------|--------|-----------------------|-----------------| | Location error | 1.3 mm | 0.5 mm | 2.2 mm | | Trajectory angle error | 0.73° | 0.34° | 1.3° | #### CONCLUSION Functionality and features considered as substantially equivalent have been verified and validated. The Cranial Image Guided Surgery System with its set of functionalities is substantially equivalent to its predicate devices.